We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gut Microbiota Reconstruction in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea

This study is currently recruiting participants.
Verified October 2017 by Shanghai Zhongshan Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02651740
First Posted: January 11, 2016
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
  Purpose
The purpose of this study is to evaluate the efficacy as well as safety of rifaximin combined fecal microbiota transplantation(Gut microbiota reconstruction) in the treatment of IBS-D.

Condition Intervention Phase
Irritable Bowel Syndrome Drug: Rifaximin Procedure: Fecal microbiota transplantation Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Evaluation of Rifaximin Combined Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea

Resource links provided by NLM:


Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • Number of patients with relief of IBS condition [ Time Frame: 6 months after the treatment ]
    The "responder" should at the same time get relief of at least one item of abdominal discomfort related symptoms(including abdominal pain score(0-10 with 0 indicates no pain and 10 indicates very great deal of pain) and bloating/abdominal discomfort score(0-10 with 0 indicates no discomfort and 10 indicates very great deal of discomfort), both items' effectiveness are defined as decreasing at least 30% compared with baseline) and at least one item of defecation related abnomalities(including average daily defecation(effectiveness defined as decreasing at least 30% compared with baseline) and stool consistency(effectiveness defined as feces could reach at least Bristol type 5) ).


Secondary Outcome Measures:
  • Number of patients with relief of IBS related anxiety or depression status [ Time Frame: 1 month/2 month/3 month/6 month after the treatment ]
    The number of patients who have at least 30% decreasing compared with baseline in the score of SAS/SDS/HADS rating scale

  • Number of patients with relief of IBS single symptoms [ Time Frame: 2 week/1 month/2 month/3 month/6 month after the treatment ]
    The number of patients who have relief of IBS global score(0-10 with 0 indicates no discomfort and 10 indicates very great deal of discomfort), pain score(0-10 with 0 indicates no pain and 10 indicates very great deal of pain), bloating/abdominal discomfort score(0-10 with 0 indicates no discomfort and 10 indicateds very great deal of discomfort), urgency score(0-3 with 0 indicates no urgency and 3 indicates great deal of urgency), average daily defecation, stool consistency(according to Bristol criteria). Except stool consistency, other items' effectiveness are defined as decreasing at least 30% compared with baseline during the whole period of follow-up. Stool consistency's effectiveness is defined as feces could reach at least Bristol type 5 during the whole period of follow-up.


Other Outcome Measures:
  • The rate and type of adverse effects [ Time Frame: The day before check-out and 2 week/1 month/2 month/3 month/6 month after the treatment ]
    It means any events that occur in the trial process related or unrelated to the drug/fecal microbiota transplantation that do harm to the patients' health, including symptoms/physical signs/abnormal lab values


Estimated Enrollment: 10
Actual Study Start Date: April 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combining therapy
taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube
Drug: Rifaximin
400mg tid* 3d
Other Name: Brand name: XIFAXAN; Production company: SALIX PHARMS
Procedure: Fecal microbiota transplantation
Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time

Detailed Description:
In this prospective study, there is only one group with no placebo/blank control. All qualified IBS-D patients could be admitted to hospital for at least one time of combing therapy (taking rifaximin for 3 days and then receiving fecal microbiota transplantation) and follow-up until 6 months after the first treatment.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 65, no gender limitation;
  • Had received a diagnosis of IBS-D (as assessed according to the Rome III diagnosis criteria of IBS) and had undergone a colonoscopic examination within the previous 2 years with no organic lesions observed;
  • Has current symptoms of IBS-D: ①Abdominal pain (at least 2 days in a week with no limitation of severity); ②Stool consistency (rated the consistency of their stools of Bristol types 6/7 at least once a day and at least 2 days in a week);
  • Can do follow-up at required time points and signed written informed consent before the study.

Exclusion Criteria:

  • Allergic to rifaximin;
  • Taking alosetron, tegaserod, lubiprostone, warfarin, or antipsychotic, antispasmodic, antidiarrheal, probiotic, or narcotic drugs within the previous 1 month;
  • Had infective diarrhea history or had taken antibiotics within the previous 14 days;
  • Patients with a history of inflammatory bowel disease ;
  • Previous abdominal surgery (other than cholecystectomy or appendectomy);
  • Human immunodeficiency virus infection or other immunodeficiency conditions such as congenital immunodeficiency or currently taking immune-suppression drugs;
  • Unstable diabetes, hypertension, thyroid disease, etc;
  • Accompanied malignant tumor or severe heart/lung/renal/hepatic/brain/blood diseases;
  • Accompanied severe neural/psychotic diseases such as epilepsy, depression, mania, schizophrenia, etc;
  • Other conditions that doctor thought not suitable for the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651740


Contacts
Contact: Shengdi Wu (86)13817923359 wu.shengdi@zs-hospital.sh.cn

Locations
China
Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: Shengdi Wu    (86)13817923359    wu.shengdi@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Study Chair: Xizhong Shen, PhD Zhongshan Hospital, Shanghai, China
  More Information

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02651740     History of Changes
Other Study ID Numbers: SXZ-WSD01-2015
First Submitted: January 6, 2016
First Posted: January 11, 2016
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shanghai Zhongshan Hospital:
Rifaximin
Fecal microbiota transplantation
Gut microbiota

Additional relevant MeSH terms:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents